U.S. patent application number 17/376798 was filed with the patent office on 2021-12-16 for deflection indicator for deflectable vascular catheter.
This patent application is currently assigned to Oscor Inc.. The applicant listed for this patent is Oscor Inc.. Invention is credited to Andrew J. Enerson, Michael John Gelineau, Chet Michael, Thomas P. Osypka.
Application Number | 20210386971 17/376798 |
Document ID | / |
Family ID | 1000005751343 |
Filed Date | 2021-12-16 |
United States Patent
Application |
20210386971 |
Kind Code |
A1 |
Osypka; Thomas P. ; et
al. |
December 16, 2021 |
DEFLECTION INDICATOR FOR DEFLECTABLE VASCULAR CATHETER
Abstract
A deflectable catheter is disclosed that includes a proximal
handle, an elongated catheter shaft extending distally from the
proximal handle and including a deflectable distal end portion, a
drive mechanism associated with the proximal handle for deflecting
the distal end portion of the catheter shaft between a first
position where the distal end portion of the catheter shaft is
aligned with an axis of the catheter shaft and a second position
where the distal end portion of the catheter shaft is deflected
angularly away from the axis of the catheter shaft, and indicator
means associated with the drive mechanism for providing a visual
indication of the position of the drive mechanism, which
corresponds to a degree of curved deflection of the deflectable
distal end portion of the catheter shaft.
Inventors: |
Osypka; Thomas P.; (Palm
Harbor, FL) ; Enerson; Andrew J.; (New Port Richey,
FL) ; Gelineau; Michael John; (Lutz, FL) ;
Michael; Chet; (Tampa, FL) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Oscor Inc. |
Palm Harbor |
FL |
US |
|
|
Assignee: |
Oscor Inc.
Palm Harbor
FL
|
Family ID: |
1000005751343 |
Appl. No.: |
17/376798 |
Filed: |
July 15, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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29737782 |
Jun 11, 2020 |
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17376798 |
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29737784 |
Jun 11, 2020 |
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29737782 |
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63052200 |
Jul 15, 2020 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00577
20130101; A61B 18/1492 20130101; A61B 2018/00345 20130101; A61B
17/3421 20130101; A61M 25/0136 20130101; A61M 2205/583
20130101 |
International
Class: |
A61M 25/01 20060101
A61M025/01; A61B 18/14 20060101 A61B018/14 |
Claims
1. A deflectable vascular catheter comprising: a) a proximal handle
assembly; b) an elongated catheter shaft extending distally from
the proximal handle assembly and including a deflectable distal end
portion; c) a drive mechanism operatively associated within an
interior cavity of the proximal handle assembly for deflecting the
distal end portion of the catheter shaft between a first position
where the distal end portion of the catheter shaft is aligned with
a longitudinal axis of the catheter shaft and a second position
where the distal end portion of the catheter shaft is deflected
angularly away from the longitudinal axis of the catheter shaft;
and d) indicator means associated with the drive mechanism for
providing a visual indication of the position of the drive
mechanism, which corresponds to a degree of curved or angular
deflection of the deflectable distal end portion of the catheter
shaft.
2. A deflectable vascular catheter as recited in claim 1, wherein
the drive mechanism includes a linear drive screw that is mounted
for reciprocal axial movement within the interior cavity of the
proximal handle assembly.
3. A deflectable vascular catheter as recited in claim 2, wherein
the indicator means includes indicia, coloring or structure
provided on or operatively associated with at least a portion of
the linear drive screw.
4. A deflectable vascular catheter as recited in claim 3, wherein a
window is formed in the proximal handle assembly at a location that
is aligned with the linear drive screw for viewing at least the
portion of the linear drive screw that includes the indicator means
as the linear drive screw moves within the interior cavity of the
proximal handle assembly to steer the distal end portion of the
catheter shaft.
5. A deflectable vascular catheter as recited in claim 4, further
comprising a rotatable control knob operatively associated with a
distal end portion of the proximal handle assembly for moving the
linear drive screw.
6. A deflectable vascular catheter as recited in claim 5, wherein
the window is located adjacent to the rotatable control knob.
7. A deflectable vascular catheter as recited in claim 1, wherein
the catheter shaft is configured as a guiding sheath.
8. A deflectable vascular catheter as recited in claim 1, wherein
the catheter shaft is configured as an ablation catheter.
9. A deflectable vascular catheter as recited in claim 1, wherein
the distal end portion of the catheter shaft is configured for a
maximum curved deflection angle that ranges from 90 degrees to 270
degrees.
10. A deflectable vascular catheter comprising: a) a proximal
handle assembly; b) an elongated catheter shaft extending distally
from the proximal handle assembly and including a deflectable
distal end portion; c) a linear drive screw mounted for axial
movement within an interior cavity of the proximal handle assembly
for effectuating angular deflection of the distal end portion of
the catheter shaft; and d) a window formed in the proximal handle
assembly at a location that is aligned with the linear drive screw
for viewing at least a portion of the linear drive screw as the
linear drive screw moves within the interior cavity of the proximal
handle assembly to steer the distal end portion of the catheter
shaft, wherein at least the portion of the linear drive screw that
is aligned with the window is of a color that is in contrast to a
color of the proximal handle assembly that surrounds the
window.
11. A deflectable vascular catheter as recited in claim 10, further
comprising a rotatable control knob operatively associated with a
distal end portion of the proximal handle assembly for moving the
linear drive screw.
12. A deflectable vascular catheter as recited in claim 11, wherein
the window is located adjacent to the rotatable control knob.
13. A deflectable vascular catheter as recited in claim 11, wherein
the catheter shaft is configured as a guiding sheath.
14. A deflectable vascular catheter as recited in claim 11, wherein
the catheter shaft is configured as an ablation catheter.
15. A deflectable vascular catheter as recited in claim 11, wherein
the distal end portion of the catheter shaft is configured for a
maximum curved deflection angle that ranges from 90 degrees to 270
degrees.
16. A deflectable vascular catheter comprising: a) a proximal
handle assembly defining a longitudinal axis; b) an elongated
catheter shaft extending distally from the proximal handle assembly
and including a deflectable distal end portion; c) a linear drive
screw mounted for axial movement within an interior cavity of the
proximal handle assembly for effectuating angular deflection of the
distal end portion of the catheter shaft; d) a deflection indicator
operatively associated with the linear drive screw and configured
to move in tandem therewith; and e) a window formed in the proximal
handle assembly at a location that is aligned with the linear drive
screw for viewing movement of the deflection indicator.
17. A deflectable vascular catheter as recited in claim 16, further
comprising a rotatable control knob operatively associated with a
distal end portion of the proximal handle assembly for moving the
linear drive screw.
18. A deflectable vascular catheter as recited in claim 16, wherein
the catheter shaft is configured as a guiding sheath.
19. A deflectable vascular catheter as recited in claim 18, wherein
the guiding sheath has a diameter of 3 F to 13 F.
20. A deflectable vascular catheter as recited in claim 16, wherein
the proximal handle assembly includes a pair of guide rods
protruding through a drive gear for guiding the drive gear, and
partially protruding into a threaded sleeve operatively connected
to an outside of the proximal handle assembly, wherein the threaded
sleeve is threadably coupled to the drive gear.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The subject application claims the benefit of priority to
U.S. Provisional Patent Application Ser. No. 63/052,200, which was
filed on Jul. 15, 2020, U.S. Design patent application Ser. No.
29/737,784, which was filed on Jun. 11, 2020, and U.S. Design
patent application Ser. No. 29/737,782, which was filed on Jun. 11,
2020, the contents of which are incorporated by reference herein in
its entirety.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The subject invention is directed to surgical
instrumentation, and more particularly, to a feature for indicating
a degree or amount of deflection associated with a distal end
portion of a deflectable vascular catheter.
2. Description of Related Art
[0003] Steerable catheters or guiding sheaths are well known in the
art. They are used for vascular access and the delivery of
therapeutic devices such as stents, anchors and drugs to targeted
areas in the vascular system of the human body. They can also be
used as vascular ablation catheters, for example in renal ablation
procedures.
[0004] Deflectable sheaths can be uni-directional or
bi-directional, and they are typically available in sheath dimeter
sizes ranging from 4 F to 20 F. These devices can be designed with
deflection angles that vary from 90 degrees to 270 degrees, and
they can be designed with various tip formations, shaft stiffness
and handle configurations.
[0005] Examples of steerable catheters or guiding sheaths with
deflectable distal end portions that are configured for use in
conjunction with the subject invention are disclosed in commonly
assigned U.S. Pat. Nos. 9,498,602; 9,572,957; 9,907,570; and
9,913,684, the disclosures of which are herein incorporated by
reference in their entireties.
[0006] The deflection curve of the distal end of the catheter
sheath allows a surgeon to access complex vasculature in a very
short period of time, as compared to the use of a non-deflectable
sheath that has a fixed distal curvature. Typically, deflectable
sheaths feature a deflection curve whereby the distal tip deflects
in a single plane. When the catheter sheath is deployed within the
vascular system of a patient, the amount of deflection is usually
determined through visual observation under X-ray of a radiopaque
marker band located on the distal-most tip of the catheter.
[0007] It would be beneficial to provide an alternative means for a
surgeon to determine the amount or degree of deflection of the
distal end portion of a steerable vascular catheter within the
vasculature of a patient, without the use of X-ray observation
techniques.
SUMMARY OF THE INVENTION
[0008] The subject invention is directed to a new and useful
deflectable vascular catheter that includes a proximal handle
assembly, an elongated catheter shaft extending distally from the
proximal handle assembly and including a deflectable distal end
portion, and a drive mechanism that is operatively associated with
an interior cavity of the proximal handle assembly for effectuating
angular deflection of the distal end portion of the catheter
shaft.
[0009] More particularly, the drive mechanism is adapted and
configured to steer or otherwise move the distal end portion of the
catheter shaft between a first position where the distal end
portion of the catheter shaft is axially aligned with a
longitudinal axis of the catheter shaft and a second position where
the distal end portion of the catheter shaft is deflected angularly
away from the longitudinal axis of the catheter shaft. It is
envisioned that the distal end portion of the catheter shaft could
be configured with a maximum curved deflection angle that ranges
from 90 degrees to 270 degrees.
[0010] In accordance with a preferred embodiment of the subject
invention, the catheter also includes indicator means associated
with the drive mechanism for providing a visual indication of the
position of the drive mechanism, which corresponds to an amount or
degree of curved or angular deflection of the deflectable distal
end portion of the catheter shaft. Thus, a surgeon can readily
determine the amount or degree of curved deflection without the use
of X-ray observation techniques.
[0011] Preferably, the drive mechanism includes a linear drive
screw that is mounted for reciprocal axial movement within the
interior cavity of the proximal handle assembly, and the indicator
means includes indicia such as numbers or symbols, contrasting
colored features, or observable structural features provided on or
associated with at least a portion of the linear drive screw. In
addition, a window or portal is formed in the proximal handle
assembly at a location that is aligned with the linear drive screw
for viewing at least the portion of the linear drive screw that
includes the indicator means as the linear drive screw moves within
the interior cavity of the proximal handle assembly to steer the
distal end portion of the catheter shaft.
[0012] The deflectable vascular catheter of the subject invention
further includes a rotatable control knob that is operatively
associated with a distal end portion of the proximal handle
assembly for moving the linear drive screw. The window is located
adjacent or proximal to the rotatable control knob. It is
envisioned that the catheter shaft could be configured as a guiding
sheath, an ablation catheter, an irrigation catheter, a drainage
catheter or the like.
[0013] The subject invention is also directed to a deflectable
vascular catheter that includes a proximal handle assembly, an
elongated catheter shaft extending distally from the proximal
handle assembly and including a deflectable distal end portion, a
linear drive screw mounted for axial movement within an interior
cavity of the proximal handle assembly for effectuating angular
deflection of the distal end portion of the catheter shaft, and a
window formed in the proximal handle assembly at a location that is
aligned with the linear drive screw for viewing at least a portion
of the linear drive screw as the linear drive screw moves within
the interior cavity of the proximal handle assembly to steer the
distal end portion of the catheter shaft, wherein at least the
portion of the linear drive screw that is aligned with the window
is of a color that is in contrast to a color of the proximal handle
assembly that surrounds the window, to provide a visual indication
to an observer of the amount or degree of deflection of the distal
end portion of the catheter shaft.
[0014] The subject invention is also directed to a deflectable
vascular catheter that includes a proximal handle assembly defining
a longitudinal axis, an elongated catheter shaft extending distally
from the proximal handle assembly and including a deflectable
distal end portion, a linear drive screw mounted for axial movement
within an interior cavity of the proximal handle assembly for
effectuating angular deflection of the distal end portion of the
catheter shaft, a deflection indicator operatively associated with
the linear drive screw and configured to move in tandem therewith,
and a window formed in the proximal handle assembly at a location
that is aligned with the linear drive screw for viewing movement of
the deflection indicator. The catheter shaft is preferably
configured as a guiding sheath, and the guiding sheath preferably
has a diameter of 4/5 F or 12 F. Here, the proximal handle assembly
is preferably no longer than 5 cm in axial length, which his unique
in the art.
[0015] These and other features of deflectable vascular catheter of
the subject invention will become more readily apparent to those
having ordinary skill in the art to which the subject invention
appertains from the following description of the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] So that those skilled in the art will readily understand how
to make and use the deflectable vascular catheter of the subject
invention without undue experimentation, reference may be made to
the figures wherein:
[0017] FIG. 1 shows a handle portion of the deflectable vascular
catheter with a deflection indication drive screw in a first
position that corresponds to the distal end portion of the catheter
shaft being aligned with a longitudinal axis of the catheter
shaft;
[0018] FIG. 2 shows the drive screw of the deflectable vascular
catheter of FIG. 1 in a second position that corresponds to the
catheter shaft being partially deflected relative to the
longitudinal axis of the catheter shaft;
[0019] FIG. 3 shows the drive screw of the deflectable vascular
catheter of FIG. 1 with the deflection indication feature of the
subject invention in a third position that corresponds to the
catheter shaft being deflected to a maximum curvature relative to
the longitudinal axis of the catheter shaft;
[0020] FIG. 4 shows a perspective view of a distal end portion of a
bidirectional ablation catheter, configured to use the drive screw
of FIG. 1, illustrating an exemplary range of curved
deflection;
[0021] FIG. 5 shows a perspective view of the deflectable vascular
catheter of FIG. 1 including a proximal handle assembly showing
another embodiment of the deflection indication feature of the
subject invention;
[0022] FIG. 6 provides a front side view of the deflectable
vascular catheter shown in FIG. 5;
[0023] FIG. 7 provides a sectional view of the deflectable vascular
catheter shown in FIG. 6, showing the inside of the handle
assembly;
[0024] FIG. 8 provides top plan view of the deflectable vascular
catheter shown in FIG. 5;
[0025] FIG. 9 provides a sectional view of the deflectable vascular
catheter shown in FIG. 8, showing the inside of the handle assembly
at a second elevation;
[0026] FIG. 10 provides an exploded view of the deflectable
vascular catheter shown in FIG. 5, with parts separated for ease of
illustration including the deflection indicator.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] Referring now to the drawings wherein like reference
numerals identify similar structural elements and features of the
subject invention, there is illustrated in FIGS. 1 through 4 a new
and useful deflectable vascular catheter that includes a proximal
handle assembly 10, an elongated catheter shaft 12 extending
distally from the proximal handle assembly 10 and including a
deflectable distal end portion 18 (shown in FIG. 4), and a linear
drive screw 14, that is operatively associated with an interior
cavity of the proximal handle assembly 10 for deflecting the distal
end portion 18 of the catheter shaft 12.
[0028] More particularly, the linear drive screw 14 is adapted and
configured to steer or otherwise move the distal end portion 18 of
the catheter shaft 12 between a first position where the distal end
portion of the catheter shaft 12 is axially aligned with a
longitudinal axis of the catheter shaft and a second position where
the distal end portion of the catheter shaft is deflected angularly
away from the longitudinal axis of the catheter shaft 12, as shown
for example in FIG. 4. It is envisioned that the distal end portion
18 of the catheter shaft 12 could be configured with a maximum
curved deflection angle that ranges from 90 degrees to 270 degrees.
It is further envisioned that the distal end portion 18 of the
catheter shaft 12 could have distance between 50 mm and 7 mm from
the proximal portion of the shaft 12 when fully deflected. The
catheter shaft 12 can also gradually narrow towards the distal
direction and have a diameter ranging from 3 F to 13 F, and
preferably from 5 F to 12 F.
[0029] In accordance with a preferred embodiment of the subject
invention, the catheter also includes a position indicator
associated with the drive screw 14 for providing a visual
indication of the position of the drive screw 14, which corresponds
to a degree of curved deflection of the deflectable distal end
portion 18 of the catheter shaft 12. It is envisioned that the
indicator means can comprise a contrasting color as shown for
example in FIGS. 2 and 3, or it could be indicia such as symbols or
numbering, or even a structural feature that is provided on at
least a portion of the linear drive screw 14.
[0030] In addition, a window or portal 20 is formed in the proximal
handle assembly 12 at a location that is aligned with the drive
screw 14 for viewing at least the portion of the drive screw 14
that includes the indicator means as the drive screw 14 moves
within the interior cavity of the proximal handle assembly 10 to
steer the distal end portion 18 of the catheter shaft 12. The drive
screw 14 provides a critical visual guide for the surgeon to
determine the amount or degree of deflection of the distal end
portion 18 of the catheter shaft 12 when navigating within the
vasculature of a patient, without having to perform visual
observation under X-ray of a radiopaque marker band located on the
distal-most tip of the catheter. The drive screw 14 not only
provides an indicator of whether the tip is neutral or deflected,
but shows the extent to which the distal end portion 18 is
deflected. An example of a bidirectional drive screw mechanism is
described in detail in commonly assigned U.S. Pat. No. 9,572,957,
the disclosure of which is herein incorporated by reference in it
entirety. It is noted that the drive screw 14 is capable of showing
the progression of bending and straightening in a first direction
and bending in a second direction as shown in FIG. 4.
[0031] The deflectable vascular catheter of the subject invention
further includes a rotatable control knob 16 that is operatively
associated with a distal end portion of the proximal handle
assembly 10 for moving or otherwise actuating the drive screw 14.
The window 20 is located adjacent or proximal to the rotatable
control knob 16.
[0032] In use, when the control knob 16 is manually rotated by a
surgeon, the colored drive shaft 14 will translate linearly within
the interior cavity of the proximal handle portion 10, causing
steering wires within the catheter shaft 12 to steer the
deflectable distal end portion 18 of the catheter shaft 12. At such
a time, the linear movement of the colored drive screw 14 is
readily observable through the window 20 in the proximal handle
portion 10, which will correspond to the amount of deflection of
the distal end portion 18 of the catheter shaft 12.
[0033] More particularly, when the deflectable distal end portion
18 of catheter shaft 12 is aligned with a longitudinal axis of the
catheter shaft 12, the colored drive screw 14 (or at least a
colored portion thereof) is not visible through or otherwise within
the window 20, as shown in FIG. 1. Then, when the deflectable
distal end portion 18 of catheter shaft 12 is deflected into a
partially curved orientation (see FIG. 4 for example), the colored
drive screw 14 (or at least a colored portion thereof) is partially
visible through or otherwise within the window 20, as shown in FIG.
2.
[0034] Finally, when the deflectable distal end portion 18 of
catheter shaft 12 is deflected into a maximum curved orientation,
the colored drive screw 14 (or at least a colored portion thereof)
is completely visible through or otherwise within the window 20, as
shown in FIG. 3. In other words, the window 20 is completely filled
with contrasting color (relative to the color of the handle portion
itself), indicating that the deflectable distal end portion 18 of
catheter shaft 12 has reached its maximum degree of curvature,
without the need for X-ray observation techniques. Alternatively,
the device could be configured so that a filled window indicates
that the distal end portion of the catheter shaft is axially
aligned and an empty widow indicates that the distal end portion of
the catheter shaft is at maximum deflection.
[0035] To the extent that X-ray observation is still necessary
during an intravascular procedure, for example, to ensure a proper
positioning of the catheter tip within the vasculature of a
patient, a marker ring 115 is located at the distal-most end of the
catheter shaft 112, as shown in FIG. 4. It is envisioned that the
catheter shaft 12 could be configured as a guiding sheath as shown
in FIGS. 1-3, or as an ablation catheter as shown in FIG. 4, which
would include a plurality of spaced apart electrode rings 117
spaced along the length of the distal end portion 118 of the
catheter shaft 112. Alternatively, the catheter shaft could be
configured as an irrigation catheter, a drainage catheter or the
like.
[0036] It is also envisioned that the deflection indication feature
of the subject invention could be employed with bi-directional
deflectable vascular catheters as shown in FIG. 4, for example and
described in detail in commonly assigned U.S. Pat. No. 9,498,602,
the disclosure of which is herein incorporated by reference in its
entirety. In such a device, there may be two separate linear drive
screws, and therefore more than one window could be provided in the
handle portion, and/or more than one contrasting color could be
used in connection with the multiple drive screws to provide a
visual indication to an observer relative to each direction of
curvature.
[0037] Referring now to the FIGS. 5-10 wherein like reference
numerals identify similar structural elements and features of the
subject there is illustrated a new and useful deflectable vascular
catheter device 600 constructed in accordance with the subject
invention. The deflectable vascular catheter 600 includes an
elongated sheath 605 extending distally from the proximal handle
assembly 601 and including a deflectable distal end portion,
similar to that shown in FIGS. 1-4. Deflectable vascular catheter
600 includes deflection knob 603 which when turned manually by the
surgeon, causes steering wires 620 within the elongated sheath 605
to steer the distal end portion of the elongated sheath 605. It is
envisioned that the distal end portion of the elongated sheath 605
could be configured with a maximum curved deflection angle that
ranges from 90 degrees to 270 degrees.
[0038] In accordance with a preferred embodiment of the subject
invention, the catheter includes an indicator 615 which shows the
user the approximate amount or degree of deflection of the distal
end portion curve through a window 616 with associated markings
(e.g., 0, 50, 100) as shown in FIG. 10 allowing the surgeon to
reach a specific curve when navigating within the vasculature of a
patient, without the use of X-ray observation techniques or
external screens. It is further considered that the deflectable
vascular catheter device 600 can include a brake lock 614. Once a
desired deflection angle is reached brake lock 614 is slid into
place to lock the drive gear 609 from further moving along guide
rods 607 and further actuating the steering wires 620, in order to
allow the surgeon to perform the next steps of the procedure
without worrying that the deflection knob 603 will turn. The moving
deflection indictor 615 is actuated when the deflection knob 603 is
twisted by the surgeon. As the deflection knob 603 is twisted the
drive gear 609 is moved along guide rods 607, and directs the
deflection indicator to move within the window 616.
[0039] The handle assembly, which includes handles 601 with finger
grips 602, for the device shown in FIGS. 6 through 11 is relatively
small, as compared to the handles of prior art devices of this
type, in that it is preferably not longer than 5 cm as compared to
15 cm or longer for handles of devices that are currently in the
marketplace, depicted as D2 in FIG. 6. This is made possible by the
compact design of the guide rods 607 and drive gear 609 sitting
within threaded sleeve 610. A sheath hub 608 sits between the guide
rods 607 and is inserted through the drive gear 609 and into the
threaded sleeve 610, and engages the sheath and pull wire 605. The
deflectable vascular catheter 600 can use a deflectable guiding
sheath 605 having a diameter range of 3 F to 13 F, and preferably
from 5 F to 12 F, shown as D1 in FIG. 6.
[0040] Threaded sleeve 610 is surrounded by a pair of catheter
supports 611 situated opposite each other. A catheter support
sleeve 612 is fitted on the outside of the distal ends of the
catheter support 611. The sheath can be supported as a distal end
of the catheter support sleeve 612 by a strain relief cap 613. The
strain relief cap 613 can be fixed to the catheter support sleeve
612 in any suitable manner (e.g., adhesive).
[0041] Referring further to FIGS. 6 and 10, window 616, covering,
the deflection indicator 615, is held in place by deflection knob
603. Deflection knob 603 is covered by an overmold grip 604 to
prevent a surgeon's hand from slipping when using the deflectable
vascular catheter device 600. A hemostatic seal 617 and a seal
retainer 618 are used on a proximate end of the deflectable
vascular catheter device 600 to minimize blood loss and embolisms
during a procedure.
[0042] While the deflectable vascular catheter of the subject
disclosure has been shown and described with reference to preferred
embodiments, those skilled in the art will readily appreciate that
changes and/or modifications may be made thereto without departing
from the scope of the subject disclosure.
* * * * *